VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER

K972686 · Smv America · KPS · Oct 14, 1997 · Radiology

Device Facts

• Record ID: K972686
• Device Name: VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
• Applicant: Smv America
• Product Code: KPS · Radiology
• Decision Date: Oct 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The VCAR option to the DST Gamma Camera and VISION Powerstation and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation produce images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The systems are intended for whole body nuclear imaging.

Device Story

Accessory upgrade for DST/DST-XL Gamma Cameras and VISION Powerstation; enables Coincident Photon Emission Computed Tomography (CPECT). Inputs: gamma ray emissions from radioisotopes (e.g., FDG) within patient body. Operation: proprietary coincidence detection electronics compare events from opposing detectors to identify simultaneous detections; software performs electronic collimation. Outputs: 2-D and 3-D reconstructed images depicting anatomical distribution of radioisotopes. Used in clinical nuclear medicine settings; operated by trained clinicians/technicians. Output used for visual interpretation of isotope distribution to aid clinical decision-making regarding patient pathology.

Clinical Evidence

Bench testing only. Performance parameters measured using industry-standard test methods to verify system specifications. No clinical data provided.

Technological Characteristics

Accessory upgrade for existing gamma cameras. Utilizes proprietary coincidence detection electronics for electronic collimation of gamma rays (60-560 keV). Supports 2-D and 3-D image reconstruction. Compatible with FDA-approved positron-emitting radioisotopes. System architecture includes detector control, processing, and display components.

Indications for Use

Indicated for whole body nuclear imaging to detect or image the distribution of radionuclides in the body or an organ, specifically utilizing electronic collimation for coincidence imaging of positron-emitting radioisotopes (e.g., FDG) in the human body.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• VCAR option to FX-80&PS (K963273)
• Penn-PET (marketed as GE Quest 300) (K930428)
• MCD option to VERTEX Epic System (K952684)

Submission Summary (Full Text)

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K972686

SMV America DS-VCAR Option 510(k)

Appendices Page 45 of 48

# Appendix X

OCT 1 4 1997

# 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

August 20, 1996 Prepared:

- SMV America Submitter : 8380 Darrow Rd. Twinsburg, Ohio 44087 [phone]
- Contact: W. Bishop VP Business Development
- System, Emission Computed Tomography Classification Name: Device: 90 KPS Classification Number: Coincidence Imaging Gamma Camera System Common or Usual Name: VCAR option to DST Gamma Camera and VISION Trade/Proprietary Name: Powerstation VCAR option to DST-XL Gamma Camera and VISION Powerstation

### Predicate Devices:

| SPONSOR | PRODUCT | Preamendment<br>Status or 510(k)<br>Number |
|---------------------------|----------------------------------------|--------------------------------------------|
| SMV America. | VCAR option to FX-80&PS | K963273 |
| UGM Medical Systems, Inc. | Penn-PET<br>(marketed as GE Quest 300) | K930428 |
| ADAC Laboratories | MCD option to VERTEX Epic<br>System | K952684 |

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## Device Description Summary:

- The VCAR option to the DST Gamma Camera and VISION Powerstation (DST&PS/VCAR) and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation are accessory upgrades to the previously cleared DST an DST-XL Gamma Cameras (K921008) and VISION Powerstation (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The DST&PS/VCAR and DST-XL&PS/VCAR utilize proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT).
- The DST&PS/VCAR and DST-XL&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The DST&PS/VCAR and DST-XL&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.

#### Intended Use:

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- The VCAR option to the DST Gamma Camera and VISION Powerstation and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation produce images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The systems are intended for whole body nuclear imaging.
#### Technological Characteristics:

- The DST&PS/VCAR and DST-XL&PS/VCAR have been designed to perform imaging of PET isotopes in a way which is very similar to traditional PET systems (e.g., the GE Quest 300) and gamma camera PET systems (e.g., SMV's VCAR option to the FX-80 Gamma Camera and Power Station, and ADAC's MCD option to the VERTEX Epic System). The DST&PS/VCAR and DST-XL&PS/VCAR is very similar to all three predicate devices.
- Each system detects radioisotope emissions from the human body and integrates the acquired emission data over time to produce an image representing a quantification of emissions from the imaged region. All three units utilize the same theory of operation.
- In all three systems, detection events from opposing detectors are compared, to determine if both detected an event almost simultaneously. Coincident events undergo additional processing to generate images which show the frequency of annihilation events due to radioisotopes in the area being imaged.
- Each of the three systems have additional post-acquisition processing systems which further manipulate the image data to perform 2-dimensional and 3 dimensional reconstructions of the imaged area.

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- In addition, all three systems are able to utilize any FDA-approved positron-emitting radioisotope (e.g., Fluorodeoxyglucose [FDG] ) to generate images.
## Summary of Testing:

Major performance parameters have been measured using industry-standard test methods to determine that the device meets its system performance specifications and performs in a fashion similar to predicate devices.

#### Conclusion:

The VCAR option for the DST and DST-XL Gamma Cameras and VISION Powerstation was developed and validated in accordance with the Company's product and software development procedures. System testing and validation demonstrates that the system meets its published specifications, performs as well as or better than the currently marketed product, and is safe and effective for its intended use.

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Image /page/3/Picture/17 description: The image shows a logo for the Department of Health. The logo features a stylized representation of three human profiles facing to the right, stacked slightly on top of each other. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the logo, with the letters oriented to be read from bottom to top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

OCT 1 4 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

William Bishop Vice President of Business Development SMV America 8380 Darrow Road Twinsburg, OH 44087

Re: K972686

VCAR option to the DST and DST-XL Gamma Cameras and VISION Powerstation Computer Dated: July 16, 1997 Received: July 17, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Bishop:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__of_l

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-----------------------------------------------------------------------------|
| 510(k) Number (if known): | K-972686 |
| Device Name: | VCAR option to DST & DST-XL Gemma Cameras and Vision Powerstation computer. |

# Nuclear Medicine Device

Indication For Use: To detect or image the distribution of radionuclides in the body or a organ, using the following technique(s).

| | YES | NO | Energy Range (keV) |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|--------------------|
| A. Planar imaging | X | | 60 - 560 keV |
| B. Whole body imaging | | | |
| C. Tomographic imaging (SPECT) for non Positron emitter | | | |
| D. Positron imaging by coincidence | X | | 60 - 560 keV |
| E. Positron imaging without coincidence | | | |
| F. Other indication(s) in the device label, but not included in above list | Indication for use of the VCR option to the DST and DST-XL cameras and Powerstation computer is an accessory upgrade intended to perform electronic collimation for coincidence imaging of positron-emitting radioisotopes in the human body. | | |

(P ease do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

I Tescription I ise_ (Per 2 | CFR 801.109)

OR

Over-the-Counter Use,

(Optional Formal 1-2-96)

David A. Seysom

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K1716610